A phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladarixin in patients with new-onset type 1 diabetes and a low residual β-cell function at baseline.

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Description

A phase 3, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of 400 mg twice a day oral ladarixin in patients with new-onset type 1 diabetes and a low residual β-cell function at baseline. It has been designed to further evaluate whether ladarixin is effective in preserving β-cell function and slowing down the progression of type 1 diabetes (T1D) in patients with a more severe disease presentation.

Details
Age

Child to Adult

Eligibility

Age 14-45 years, within 100 days of type 1 diabetes diagnosis

Ages 14-45, diagnosed with T1D, within 100 days of first insulin administration, currently using insulin therapy, positive for 1 or more T1D auto-antibodies, no other chronic illnesses, otherwise healthy, not pregnant or breastfeeding.

Type of Study

Treatment

Locations

Barbara Davis Center
University of Colorado Hospital

Principal Investigator
Photograph of Andrea Steck,  MD

Andrea Steck, MD

Study ID

Protocol Number: 21-2474

More information available at ClinicalTrials.gov: NCT04628481

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